Pain Relief After Forefoot Surgery

NCT01019005 | Unknown DMC

• 2 other identifiers: QMC-1975-HJQMC-1975-NB
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.

Conditions

Orthopedic Surgery

Keywords

post-operative analgesia; opioid; catheter; tibial nerve block

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  2,8,12,24,48 hr

Study Arms (3)

Tibial

EXPERIMENTAL

Device: Catheter

Wound

EXPERIMENTAL

Device: Catheter

Sham

NO INTERVENTION

Device: Catheter

Interventions

Catheter DEVICE

Catheter inserted into either perineural tibial nerve or wound

Sham; Tibial; Wound

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older (ASA I \& II)
• Able to give written consent
• Patients having elective forefoot surgery with a planned ankle block.
• Expected postoperative pain to be at least moderate in severity the day following surgery

You may not qualify if:

• Refusal
• Inability to communicate
• History of alcohol or opioid abuse (also chronic opioid user)
• Mental or medical conditions which may affect quantifying pain scores (VAS)

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

Catheters

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

GB (1)